Cleared Traditional

SUNSOR ULTRAVIOLET METER (K934728) - FDA 510(k) Clearance

Class II Dental device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K934728 · Sunsor, Inc. · Dental device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1994
Decision
302d
Days
Class 2
Risk

K934728 is an FDA 510(k) clearance for the SUNSOR ULTRAVIOLET METER. Classified as Detector, Ultraviolet (product code EAQ), Class II - Special Controls.

Submitted by Sunsor, Inc. (Pittsburgh, US). The FDA issued a Cleared decision on July 28, 1994 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Dental FDA review panel, regulated under 21 CFR 872.6350 - the FDA dental device regulatory framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Dental review framework, consistent with the majority of Class II 510(k) submissions.

View all Sunsor, Inc. devices

Submission Details

510(k) Number K934728 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 1993
Decision Date July 28, 1994
Days to Decision 302 days
Submission Type Traditional
Review Panel Dental (DE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
175d slower than avg
Panel avg: 127d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code EAQ Detector, Ultraviolet
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.6350
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Dental devices follow this clearance model.